PP 39 | FDA CBD Report

 

The FDA has addressed a report to the US House Committee of Appropriations and the US Senate Committee of Appropriations concerning CBD. On today’s show, Tony Frischknecht looks into this report and reflects back on some similar meetings that took place in 2008-2009 about medical cannabis, relating it to the current issue at hand. He highlights the concerns he has about the report, mainly the associated health risks of CBD that were pointed out. He also points out that included in the report is FDA’s willingness to open their doors for discussions. Tread carefully when dealing with the federal government. Learn more about this report for further information.

Listen to the podcast here:

The Body And CBD: An FDA Report

Thanks for joining me. I’ve got some news I want to share with you guys. I’ve read a recent report put out by the FDA on CBD. This report has some pretty significant stuff in it. It’s about twenty pages or so. This report is to the US House Committee of Appropriations and the US Senate Committee of Appropriations on CBD. This report has some major information that I think our hemp CBD guys should be aware of. In May 2019, there was a public hearing that the FDA put on. Six hundred participants showed up and 4,500 comments submitted. There were 100 speakers and they had 2,300 people that were remotely joined.

From what it looks like to me, most of the people that were in attendance were pro-CBD. It’s a good thing. I’m sure they had a little bit of opposition but nothing more. Everything was very similar when we had medical marijuana hearings down at the city buildings. We’d have a couple of hundred people down there going back to the 2009, 2008 time period. We would be in a small auditorium area where we didn’t know too many people but there was a lot of pro-marijuana. We have 75 to 100 people that would go up and speak. You figured 95% of them were pro-cannabis. You had 5% that were police officers, probation officers, and some kind of a law enforcement person out there.

PP 39 | FDA CBD Report

FDA CBD Report: You have to tread cautiously as you dip into the world of the FDA.

 

I remember watching some of the activists come up on stage. At the time, we called them activists because they were pro-cannabis, which was awesome, but they were over the top a little bit. At that point, we were trying to get as much credibility as possible. As a new business owner in a new industry showing the city that we were the real deal, sometimes it would be frustrating because we didn’t want to be lumped in as these activists with cannabis. They wouldn’t take us seriously. At each meeting, we would get a little bit better voice out and a little bit more business happening. Nowadays, it’s made it there but at the time, we were hoping somebody would listen to us and take us seriously. I can imagine at this CBD hearing, there were similar vibes to that. It’s funny to think back that far when they stuffed us into some little auditorium somewhere. I can see that happening.

Back to the report, I want you to check this out. If you go to the FDA website, you should be able to find this report in there. The concerning thing that I noticed in reading this is that they have come up with some associated risks from CBD. They say there are potential risks, including liver injury, drowsiness, and potential for drug interaction. Taking it with any kind of prescription drugs, you could have an adverse reaction. I’ve heard people have reactions if they’re taking vitamin C, it counteracts their medication. The other thing that was a little concerning was they did some animal studies and found risks, including those related to male reproductive toxicity. I’m not sure what that means, but that doesn’t sound good.

At this point, the only drug that is FDA approved is Epidiolex, which is the epilepsy pill made by GW Pharmaceuticals. They launched this in Europe in Q1 of 2020. We should start hearing about that. That was good because we got some more feedback on this drug as it is. I don’t want to read through the whole thing. I tried that and it didn’t seem to make a lot of sense, at least. There’s a lot of good information here but the meat to this report is that the FDA is leaving its doors open to have further discussions. What does that mean? It’s hard to say. Maybe they’re saying, “Come share your data with us. We want to learn more about this.” This is a new territory for cannabis. You have to tread cautiously as you dip into the world of the FDA.

Somebody told me a long time ago that in Colorado, we have this Medical Marijuana Enforcement Division. These are enforcement guys and so is the FDA. You are dealing with the police. Remember that as you open up your doors. Police officers see a lot of black and white. There’s not a lot of gray area. Keep that in mind. I’m not trying to scare you out there, guys. I’m saying that these are little things that I think about when you’re dealing with the federal government. Think about that. Please talk to your attorney first. Don’t go in there blindly. Make sure you understand what you’re getting into, especially if you’re developing a product.

Don’t invest time and money into something where you suddenly get your dreams smashed for not paying attention to what is happening locally. Click To Tweet

If you’re going to develop the next product and you want to be regulated as a high-quality supplement, or even as a drug, if you want to go through the application process with the FDA, you got to know what you’re doing. Make sure that you know what you’re getting into. You don’t want to start down this road and put all this time and effort into it and figure out that you need $10 million to put something together. You don’t want to waste your time doing that. A lot of these big drug companies have been doing this for a long time. They know how the processes work. As a little guy, it’s not impossible to pull off.

That’s what’s great about cannabis and hemp CBD. There are big guys that know what they’re doing. People are acting as if but there’s nobody that is dominating the market. That’s great for you as a business owner and as an individual. Think about that. It’s not dominated yet. There are a few players that are involved. You could potentially be one of the main guys. I’d say that with a smile but I’m dead serious. With that opportunity that’s available out there to you, it’s hard not to get into this industry. It is exciting but start thinking about the timing and the place you’re in. We’ve got the Corona Virus happening, but there are some big doors opening for cannabis that was not there because the market hasn’t matured.

PP 39 | FDA CBD Report

 

Because of the Corona Virus in 2020, we started to see that there was a dip. It looked like we’ve seen some massive sales come out of the lockdown because that’s what it is. It’s been a bit trying on a lot of people mentally. It’s been a little bit tough on me, too, because I spend a significant amount of time thinking about what I can produce for you. That’s what’s going to be helpful for the business owner and the investor. I am seeing some doors open up that makes me want to jump into this on a large scale. Sometimes, I look at this and be like, “I want to take care of that. I would love to get into this.”

I have to remember my place a lot of the time because I have a lot of irons in the fire, too. I’ve got to be careful. I do see some massive opportunities ready to pop even with the downturn in the market. People are concerned about that opportunity. I didn’t mean to get too far off track. What I see could be looked at as negatively with the FDA report. I think it is but you have a lot of opportunities to change that and to take advantage of that if you want to dig further into it. If you’re heavily into CBD, like I said before, I would suggest exploring. You have to read this report. You don’t want to invest a ton of time and money into this.

All of a sudden, your dreams are smashed because you aren’t paying attention to what is happening locally. I talked about this in several other episodes. One of them was the association. Association groups are getting involved. Get involved with some association groups. Read this report. Tie into it, see how you can help mold and shape this thing ao the FDA doesn’t come in, close your product down, or nail you for some off-labeling issues. Things like that will finish your business and I don’t want that to happen to you guys. I just want to drop you guys a little bit of information. It’s a short one but I thought it was important. Thanks for joining me. Bye for now.

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